One of the strategies that Stanislaw Burzynski will undoubtedly use to “prove” in Eric Merola’s new Stanislaw Burzynski movie that antineoplastons work in cancer will be to highlight “success stories.” Last year, Burzynski apologists frequently pointed to a girl with an inoperable brain tumor named Amelia Saunders as a success story when the U.K. press widely featured her going to school in September but, very sadly, her family saw her tumor begin to progress again in December, ultimately resulting in her death about a month and a half ago. In the process, Burzynski did what he all too often does and misinterpreted her MRI, in which cystic structures commonly seen in Amelia’s form of cancer as it progresses were seen, as evidence that her tumor was regressing. They were not.

So let’s take a look at two cases frequently pointed out to me as Burzynski success stories: Laura Hymas (whose website is Hope for Laura) and the aforementioned Hannah Bradley (whose website is Team Hannah). On the surface to those not familiar with cancer they do look like success stories. If one digs deeper, the true story is a lot murkier. More importantly, as I will show, even if they really are success stories—which is not at all clear—they do not constitute convincing evidence of the efficacy of Burzynski’s antineoplastons for cancer patients in general, nor do they justify what I consider to be Burzynski’s highly unethical behavior.

Go Team Hannah!

I will start with Hannah Bradley’s story because I’ve watched the entire 40 minute video Hannah’s Anecdote. The documentary ends triumphantly several months after the events portrayed during the bulk of the film with Hannah apparently having had a complete response to Burzynski’s antineoplaston therapy:

Let me just first say something before I begin my usual analysis. I love these two. I really do. They are the cutest couple, and their love for each other oozes from the video and envelopes the viewer, sucking him in like The Blob, but in a good way. The same is true of every video of them I’ve watched on their video blog. Yes, it’s true that Hannah Bradley’s partner Pete Cohen can be a bit cloying and annoying at times with his seeming desire to videotape everything, but I want Pete and Hannah to be able to live a long and full life together, growing old in each other’s company. I really do. In fact, I’d love to hang with these two and maybe buy them a pint or two at their local pub (except that it’s pointed out multiple times that Hannah can no longer drink alcohol). Sadly, this is unlikely ever to pass even if Hannah does completely beat her disease and is still around the next time I make it to London (which is likely to be at least a year or two), because I fear that if they see this (which is likely) they will misinterpret my analysis as trying to destroy their hope. Certainly the families of other cancer patients who have gone the “alternative” route, be it Burzynski’s treatment or other “alternative” cancer therapy, have attacked me in that way. Such is not my intent, but what are skeptics supposed to do? Shy away from undertaking a dispassionate analysis of patient anecdotes used to promote dubious cancer therapies for fear of what patients will say?

After talking about how he needed to raise £200,000 in order to take Hannah Bradley to the Burzynski Clinic for what he characterizes as “life-saving” treatment, a campaign that produced media coverage in the form of articles with titles like ‘I’ll try anything to beat brain cancer’, Pete Cohen describes Hannah’s diagnosis, and elsewhere we find out that Hannah underwent awake brain surgery as the surgeons tried to remove all the tumor:

I first met Hannah in April 2010 and we fell in love and since then our relationship has gone from strength to strength. Hannah is 28, has a great personality and has a fantastic sense of humour. Our world took a dramatic turn in February 2011 when, out of the blue, Hannah had a major seizure in the middle of the night. She lost consciousness and was rushed to hospital.

Hannah does not remember much about the two months that followed as she had constant headaches and a number of seizures. She was diagnosed with a very serious brain tumour called Anaplastic Astrocytoma. Hannah decided to have surgery and the 1st of April 2011 and underwent a six and a half hour operation. She was awake for nearly three hours of this operation.

The operation was a success and they managed to remove nearly all of the tumour. We had to wait for the results of the biopsy for a few weeks and we remained positive. However, the news was not good and our world was rocked once more as the results showed a Grade III tumour. Hannah’s bravery and resolve once again rose up as shortly after this she started a six week course of radiotherapy. This went well for the first few weeks but was followed by Hannah’s hair falling out and bouts of tiredness and lethargy.

On top of all of this, Hannah has been dealing with losing her driving licence as she has had a number of seizures and now has epilepsy.

Six weeks after the radiotherapy finished, Hannah had another MRI to see what was going on with the tumour, Once again more bad news, as there were still remnants of this aggressive tumour.

Hannah’s treatment options are very limited and her life expectancy is for this type of tumour is normally around 18 months and this is why I started a mission to find people who had the same condition and are still alive today. I managed to track down a number of these people to speak to them.

In his movie, Pete points out that these people all led back to Burzynski. Of course, as I’ve said before, dead patients don’t produce testimonials for alternative cancer cures. More importantly, Burzynski has a network of true believers, such as the Burzynski Patient Group and a filmmaker like Eric Merola, all of whom actively promote the Burzynski Clinic online. Add to that Suzanne Somers, who included Burzynski as one of her “doctors who are curing cancer” in her book Knockout: Interviews with Doctors Who Are Curing Cancer and How To Avoid Getting It in the First Place. Indeed, Chapter 7 is all about Burzynski, whom Somers describes as having invented “the most important and successful non-FDA-approved alternative cancer drug therapy ever in this country.”

In any case, that was the end of July 2011. By November 2011, Pete had raised £35,000, which was enough to go to Houston, and that’s where his documentary begins, as he and Hannah are preparing to fly to Houston in December 2011 to have a consultation at the Burzynski Clinic. These are interspersed with footage from earlier in which the couple document their quest, talk about how they were warned by their oncologists and other doctors not to waste their money and effort, and talk about their hopes. Not long after they appear at the Burzynski Clinic, they meet with doctors there who tell them that Hannah’s most recent MRI scan showed progression of her tumor (around 8:30 in the movie). Now, I’m not a radiologist, much less a neuroradiologist, but I wondered at all the enhancement on the superficial area of the brain, just under where her neurosurgeon must have raised the bone flap to remove what he could of the tumor. One wonders if much of the remaining enhancement could be still post-surgical and post-radiation change. Certainly, the tumor is cystic-appearing, and after surgery such cysts would likely shrink and be reabsorbed even if the tumor were to keep growing.

Be that as it may, there were a number of things I found very interesting in this video. First, one notes that patients don’t see the great Dr. Burzynski right away. Underlings see them first and commence treatment, assuring the patient that Dr. Burzynski is aware of what they are planning. Second, I’m not particularly impressed with the sterile technique used for putting her Hickman catheter in, nor am I particularly impressed with the sterile technique used to access it by the nurses, who appear to be rather inconsistent about wearing gloves and a mask when accessing the line.

As important as sterile technique is when inserting and accessing long-term indwelling catheters, these complaints are quibbles compared to what this video shows about antineoplaston therapy. First, I notice that nowhere was there anything mentioned about enrolling Hannah on a clinical trial. Remember, part of the consent agreement with the Texas Attorney General back in the late 1990s stated that Burzynski can distribute “antineoplastons” only to patients enrolled in FDA-approved clinical trials, unless or until the FDA approves his drugs for sale. Given what a thorough videographer Pete Cohen obviously is, I find this omission very curious. Certainly, given how much detail he’s used in this video and in his vlogs I’d expect that if the subject of clinical trials was mentioned he would have included it.

The other thing that struck me was just how much Burzynski is full of it when he advertises antineoplastons as not being chemotherapy and, more importantly, as being nontoxic. At least a third of the video consisted of the difficulties that Hannah had with her treatment, including high fevers, a trip to the emergency room, and multiple times when the antineoplaston treatment was stopped. She routinely developed fevers to 102° F, and in one scene her fever reached 103.9° F. She felt miserable, nauseated and weak. I’ve seen chemotherapy patients suffer less. I was also very puzzled at how the Burzynski Clinic could allow a cancer patient to linger with a fever of 102° F and sometimes higher, accompanied by shaking chills, in a temporary lodging without admitting her to the hospital. It’s not clear what sort of workup was done to evaluate Hannah either, what her white blood cell count was, or what her other labs were. Did they draw blood cultures? Did they get urinalyses and cultures? Did they do chest X-rays to rule out pneumonia? It’s all very unclear, other than that she apparently was given some antibiotics at some point. Did she have the flu, given her flu-like symptoms, or was this due to her antineoplaston therapy? The reaction of the clinic staff (i.e., rather blasé, even though at one point Hannah clearly demonstrates a change in mental status, appearing “drunk” and complaining of double-vision) made me wonder if this sort of problem was a common occurrence. At another point, Pete and Hannah come to believe that the fevers might have been due to the tumor breaking down, which strikes me as implausible. Later, she develops an extensive rash. It’s difficult to tell for sure what it is at the resolution of the video, but it looks like erythema multiforme, which is generally an allergic rash. What’s the most likely cause of such a rash? Guess. Erythema multiforme is usually a drug reaction.

Near the end of the video, we see a series of MRIs. Hannah and Pete are told that the first MRI, done about a month after the antineoplaston therapy started, shows that the tumor has decreased in enhancement and size, with a decrease of about 10%. I don’t know who this person is at the Houston Medical Imaging facility just up the road from the Burzynski Clinic is, but from what I could see it isn’t clear at all that the tumor decreased in size by 10%. In fact, it’s rather hard to tell if a tumor has decreased in size at all. With a tumor that size detecting a 10% decrease in size is almost within the margin of error of the test. Even Burzynski didn’t try to sell this as a true decrease; he called it stable disease, which is what it was:

However, later in the video, there are more convincing MRIs. Indeed, the MRI dated July 29, 2012 looks quite good, with little or no enhancement left. The question, of course, is: Does this mean that Burzynski’s antineoplaston treatment worked for Hannah? Sadly, the answer is: Not necessarily. It might have. It might not have. Why do I say this? First, she didn’t have much residual disease after surgery and radiotherapy, and in fact it’s hard to tell how much is tumor and how much is postop and radiation effect. Second, the median survival for anaplastic astrocytoma (which is a form of glioma) is around 2 to 3 years, and with different types of radiation therapy five year survival is around 15% or even higher. Thus, long term survival for patients with astrocytomas is not so rare that Hannah’s survival is so unlikely that the most reasonable assumption has to be that it was Burzynski’s treatment that saved her. More likely, Hannah is a fortunate outlier, although it’s hard for me to say even that because, at only two years out from her initial diagnosis, she’s only just reached the lower end of the range of reported median survival times for her disease.

I’m also very worried about Hannah. Her last couple of vlogs are the reason. For instance, in her vlog of December 2, 2012, in marked contrast to past vlogs, Pete is noticeably evasive when discussing her latest scan, and both Pete and Hannah appear uncomfortable:

It’s been a long time coming but here is our new Team Hannah Blog. I am sorry we don’t have the best of news but I am ok. http://www.teamhannah.com/2012/11/01/team-hannah-blog-011112/

The vlog entry referenced no longer exists. I have, however, managed to obtain a copy, thanks to a reader, and it’s very, very worrisome. By all indications from that vlog, it sure sounds as though Hannah did have a recurrence. Hannah and Pete describe two scans after Hannah’s late August scan (the one that they posted on Hannah’s Facebook page), the first of which apparently showed a mass (although apparently Burzynski told them they couldn’t tell if it was scar tissue or tumor). Per Pete and Hannah, the Burzynski Clinic upped the dose of antineoplastons, which strongly implies to me that Burzynski thought it was tumor, but apparently by the second scan near the end of October the tumor hadn’t regressed. Hannah and Pete apologize for having taken more than two months between vlogs, saying that they didn’t want to give bad news in their first vlog after having released “Hannah’s Anecdote,” given that the first scan that showed probable tumor recurrence. They decided to wait until the second scan to do a vlog because they expected the second scan to show regression of disease again (i.e., good news to report). Depressingly, it appears not to have shown that.

I’m more worried about Hannah than ever. Indeed, I almost fear to say what I feel obligated to say, because no matter how I do it, it’s likely to be spun, as Merola’s movie clearly has done to other skeptics with his ham-fisted shots of cancer patients crying about how skeptics are “attacking” them, as an “attack” on Hannah and Pete or as trying to rob them of hope. I also realize that there is a fine line between trying to use a case like Hannah Bradley’s as a means of educating the public about ineffective cancer “cures” and coming off as attacking someone with a serious cancer. I try very hard not to cross that line, and I think I’ve been successful. However, if there’s one thing I’ve learned during all these years, it’s that if the person I’m discussing finds out about my post, that person always perceives it as an attack and lashes out. Similarly, Burzynski’s groupies realize that it is very effective to appeal to emotions and cast Burzynski’s critics as heartless villains so in the thrall of big pharma, ideology, or whatever that they will viciously rip into a patient whose life is threatened with a deadly cancer. Personally, I’d be very happy for Hannah and Pete if she were to survive to outlive me, whether it were due to conventional therapy, Burzynski’s therapy, or a combination of the two. I hate seeing people die of cancer, which is one big reason I became a surgical oncologist in the first place. And if it were Burzynski’s antineoplastons that did the trick, I’d be both happy at the discovery and furious at Burzynski for jerking people around for so many decades instead of doing the work it takes to prove the value of his treatment.

So why am I even more worried than ever about Hannah? It started right from the first shot of her latest vlog. Look at her face. It’s subtle, but, I think real: an increased asymmetry in which her lower lip on the left part of her face is droopier than I had ever noticed before. I first noticed this in her Christmas vlog but it appears worse now, particularly in comparison to her in the 40 minute Hannah’s Anecdote, which included lots of shots of her from December 2011 and January 2012. In those shots, she appeared to have had a bit of this going on then, but it was quite subtle. It’s not so subtle anymore in her latest vlog and suggests that the tumor might be growing and impinging on nerves going to her face. She also struggles for words in a way that I don’t recall ever having seen her do before. At one point, she has a hard time thinking of the word “risk” and has to be prompted by Pete. All of this makes me wonder if she’s developed an anomic aphasia. I could be wrong about Hannah’s facial asymmetry; I’m not a neurologist. I’m also less sure about the aphasia; it could well be that she simply had a bit of difficulty finding a word, no worse than any other person. In fact, I’d like to be wrong about this (and any neurologists and/or neurosurgeons out there reading tell me if I’m wrong about this—I’ll tack on an addendum if you convince me). But I don’t think I am, at least not about the facial asymmetry.

Next, Hannah admits that she has a “really cystic area in my head” but insists that there’s no enhancing tumor and doesn’t really say if what is there is increasing in size or stable. Given her affect and the expression on her face when she discusses these issues, I truly fear that it must be growing. There’s also the issue of the marked change in how she and Pete discuss her scans. In Hannah’s Anecdote and their vlog of July 27, 2012, Hannah and Pete exult (and understandably so!) that Hannah has had a “complete response.” Now, “complete response” means just that: a complete response to therapy. No tumor detectable by MRI. That implies that anything seen on imaging now must have arisen between the scan of last August and now. Presumably, it arose between August and November, the time when she and Pete first noted that the news was “not the best of news.” Shades of Amelia Saunders. Hers was a truly heartbreaking story, not the least of which because of the way that Stanislaw Burzynski appears to have strung the family along. I fear that he is doing the same with Pete and Hannah, who don’t deserve that any more than Amelia and her family did.

Is there Hope for Laura?

The other Burzynski success story that Burzynski supporters dare us to take on is that of Laura Hymas, whose website Hope for Laura. Her story is described on her website thusly:

Laura was diagnosed with an Oligodendroglioma, which is a rare brain cancer and in the UK there is no cure. The tumour goes deep into the brain and is in a location that is inoperable so our doctors applied a “watch and wait” approach which is standard for this type of cancer where you have a scan every three months to see if anything changes rather than applying treatment. However we recently had worse news in April 2011 Lauras MRI scan revealed growth and changes, she had a biopsy and we learnt that the tumour had progressed into a Glioblastoma Multiforme which is the most agressive type of brain cancer with a much poorer prognosis.

Many aspects of Laura’s story are similar to Hannah’s story, but one thing is different in that she started out with a less aggressive tumor, which was managed by “watchful waiting” for a time, until the tumor progressed. More details can be found at her page on the Burzynski Patient Group website. Laura started having more seizures; she was unable to care for her son; she felt as though her “life was slipping away,” and so it appeared to be. Then, like Hannah, she decided to go to Houston to the Burzynski Clinic, and like Hannah and Pete Laura and her fiance started raising money, succeeding in raising £100,000 in just a few weeks from donations. What happened next is described here:

I have now been on antineoplaston therapy since the 8th August 2011. The side effects I have suffered are tiredness, a skin rash which subsided after a few days when I began treatment and a severe thirst! The medicine is rich in sodium and I have to infuse 2 litres of it daily (a dose which lasts 90 minutes every 4 hours 24/7) so I drink approx 5 litres of water daily. This is a very full on treatment; it isn’t making me feel ill but while the pump is running it does affect my day to day decisions like for example going shopping or Ben is driving us to see family far away I need water to drink and a toilet close by! I am carrying around an infusion pump all day connected to my Hickman line in my chest. It’s like having another baby!

To be honest though, for me it’s really worth it. I won’t be connected to the medicine pump forever! I have an MRI scan at a private hospital every 6 weeks. When we came home in August it took me until the middle of October to slowly increase my antineoplaston dose up to “maintenance dose” – this is the dose that Dr Burzynski deems is most effective for my body weight.

Then six weeks later on the 29th November 2011 scan my tumour started shrinking, by 36%. On the 10th January 2012 I had another scan – 56% tumour decrease!

I just had a scan on the 21st February and it was even better news – 77% tumour decrease!

As of August 2012 there is now no trace of my Tumor at all. I always get a second opinion from a UK radiologist who confirms there is just a cavity left which should resolve over time.

So is Laura’s case proof that there’s something to Burzynski’s treatments? Is the fact that Burzynski has apparently discharged Laura as a patient slam-dunk evidence that Burzynski has cured her of her incurable tumor? Sadly, no.

The responsiveness of glioblastoma multiformes to radiotherapy varies. In many instances, radiotherapy can induce a phase of remission, often marked with stability or regression of neurologic deficits as well as diminution in the size of the contrast-enhancing mass. Unfortunately, any period of response is short-lived because the tumor typically recurs within 1 year, resulting in further clinical deterioration and the appearance of an expansile region of contrast enhancement

Moreover, complete remissions in glioblastoma do occur. They’re very uncommon—rare, even—but they do occur. There are case reports in the literature, such as this one, and a recent series describes the outcomes of long-term glioblastoma survivors as rare, but increasingly common. The bottom line is that we don’t know why Laura is still alive. It’s possible that it was the antineoplastons; it’s possible that it was the radiation therapy alone.

Moreover, discharging a patient after her treatment for cancer is complete is something real oncologists almost never do right away. They usually follow their patients, often for five years, sometimes even longer. At this point, Laura is less than six months out from the first MRI scan showing no residual tumor, and she only just finished her antineoplaston therapy. Next, keeping an open mind I will admit that Laura’s case is more suggestive of an antitumor effect due to antineoplaston therapy than Hannah’s case is. What I find curious is the delayed effect. Laura started her therapy on August 8, 2011 but it was not until nearly four months later that the tumor showed evidence of shrinking. That’s a long time for an active therapy to start to work, particularly for a tumor that is as aggressive as a glioblastoma. It’s possible, but in general, even if antineoplastons really saved Laura, a treatment that takes three or four months to kick in is generally not that enthusiastically embraced by oncologists. Basically, Laura Hymas’ case seems a bit more consistent with an antitumor effect due to antineoplastons than Hannah Bradley’s case, but it is only a single case.

So what might be going on here?

Antineoplastons versus sodium phenylbutyrate

Back in late 2011, when I first took a serious interest in Stanislaw Burzynski and what he’s been doing, I wrote a three-part series in which I (1) analyzed Burzynski The Movie, its claims, and whether there was any evidence that antineoplastons do anything for cancer; (2) discussed why Burzynski’s claims that his “personalized gene-target cancer therapy” are overblown and nonsensical; and (3) how there might be a way to understand how antineoplastons might actually be real drugs, with the problem, of course, being that, when it comes to demonstrating efficacy, Burzynski is doing it wrong—very wrong indeed. They say that even a blind squirrel occasionally finds an acorn. Is it possible that antineoplastons are the acorn that Burzynski found?

Sodium phenylbutyrate (figure 1), a HDACI, is an aromatic fatty acid that is converted/oxidized in vivo into phenylacetate (PAA) by β-oxidation.[11] In humans the so formed PAA is eliminated by conjugation with glutamine to form phenacetylglutamine, which is excreted in the urine. This metabolic pathway is the mechanism by which phenylbutyrate acts as an ammonia scavenger in patients with urea cycle disorders (UCDs) and hyperammonemia.

If you peruse ClinicalTrials.gov for Burzynski’s current clinical trials, you’ll find that pretty much all of them use antineoplastons AS-2.1 and A-10; i.e., phenylacetic acid (PA) and phenyl acetyl glutamine (PAG). It turns out that PB is a prodrug for PA and PAG, which means that the drug is converted into an active metabolite to work. What Burzynski calls antineoplastons are nothing more than the byproducts of the body’s metabolism of the orphan drug sodium phenylbutyrate. In fact, according to this report, the “conversion of phenylbutyrate to phenylacetate was extensive (80 ± 12.6%), but serum concentrations of phenylacetate were low owing to rapid, subsequent conversion to phenylacetylglutamine.” In other words, phenylbutyrate is nearly completely converted to PA, which is then rapidly converted to PAG.

Remember my post about the use and abuse of the term “epigenetics” by various questionable practitioners, in which epigenetic effects and changes are invoked not unlike magic (or like another favorite buzzword “quantum”) to “explain” why various woo works? In that post, I explained a bit about epigenetics and why it’s a hot area in cancer research, as well as why histone deacetylase (HDAC) inhibitors are a promising new avenue for cancer therapy. I also puzzled about why HDAC inhibitors are considered “targeted,” given that they have the potential to affect huge swaths of chromatin and the expression of the genes in the DNA therein, but that’s just me. I guess I can’t fault Burzynski too much for “talking the talk,” even though it’s quite clear that when it comes to targeted therapy he doesn’t know what he is talking about, as has been amply documented. Indeed, Burzynski is so arrogant that he recently gave an interview in which he claimed to have been a pioneer — perhaps even the originator — of the concept of gene-targeted cancer therapy back in the 1990s. It’s utter rot, of course, but Burzynski really did make that claim.

Perusing the article, I find there is a fair amount of preclinical evidence that PB has antitumor effects in certain tumor types, specifically colon carcinoma, Burkitt lymphoma, primary acute myeloid leukemia, retinoblastoma, prostate cancer, U138 MG, T98G, U373 MG and A-172 glioma cells, medulloblastoma, and hepatocellular carcinoma. Ironically, however, its ability to pass the blood-brain barrier is a problem, which makes it odd that Burzynski keeps using it for brain tumors. In these preclinical models, PB shows evidence of being an HDAC inhibitor, chemical chaperone, and pro-differentiation agent. The clinical evidence is much less impressive, however. Indeed, I reviewed the clinical evidence for PB as an anticancer therapy the last time I discussed this, and all I found was a bunch of phase I studies showing safety but no real efficacy. Of course, phase I studies aren’t designed to show efficacy, but often investigators can get a hint of whether a drug is likely to have activity from phase I results. There was also a case report from 2002 showing a durable remission for four years in a malignant glioma treated with PB.

Given the impending release of Burzynski II, I decided to update my search, to see if there was anything more recent about PB and cancer. Of the references I found on PubMed, there were no new clinical trials published over the last 14 months since my last review. There were a few preclinical studies using cell culture and mouse models, but nothing new in human subjects. The state of our knowledge regarding PB and cancer can thus be correctly said to be more or less unchanged since late 2011. If Dr. Hideaki Tsuda, the Japanese anesthesiologist at Kurume University Hospital is correct when he states in the second trailer for the Burzynski sequel that he has done a randomized controlled clinical trial demonstrating the efficacy of antineoplastons in metastatic colorectal cancer, that would be the first convincing clinical evidence that antineoplastons (excuse me, PB) have significant efficacy in any cancer.

Of course, Tsuda hasn’t published the results of his clinical trial, which makes me wonder why he’s appearing in Burzynski II touting the results of his study when it hasn’t been published yet. The last study I see from his group is a study from 2005 examining breast cancer cell lines, although there is a case study from 2003 looking at colon cancer that shows mildly promising results. As Elton John would sing, I’ve seen that movie too. Burzynski’s been claiming he’ll publish the results of his clinical trials for decades now. Tsuda has been collaborating with Burzynski for over 25 years. Am I going to hold my breath waiting for him to publish the results of this randomized clinical trial he’s touting in the trailer? Not really. It’s time for Burzynski and Tsuda to put up or shut up.

The bottom line

So we come full circle, back to the question of whether the cases of Hannah Bradley and Laura Hymas are convincing evidence that Burzynski’s antineoplaston treatment works. Contrary to what Burzynski defenders claim, I started out agnostic regarding the question of whether antineoplastons have any value in cancer therapy. What I objected to was how Burzynski has continued to use them in patients and, in my opinion, abused the clinical trial process as a means of continuing to use them. Burzynski’s motivations and ethics aside, considering these cases and their (so far) good outcomes from from a purely scientific and medical standpoint, we have three possibilities:

Spontaneous remission

Treatment effect due to conventional therapy

Treatment effect due to antineoplastons

Note that the second and third possibilities are not mutually exclusive. Both could be operative. Combination therapy is the rule these days.

Given that spontaneous remission is rare in malignant brain tumors, possibility #1 is highly unlikely, albeit not completely impossible. In Hannah’s case, I tend to conclude that most likely possibility #2 is primarily at work here, although it’s not possible to exclude a contribution from possibility #3. The reason I conclude this is that the shrinkage of the enhancing part of her tumor is not outside the range of range of effects that can be observed due to her radiation therapy in mid-2011 in that the enhancing mass of her tumor continued to decrease in size. Given the biology of her tumor, a year and a half since her radiation therapy was completed is too short a time to conclude that Hannah is an antineoplaston success story, particularly in light of her more recent reports that make me suspect that her tumor might have recurred. How else can I explain their rather evasive comments in their last two vlogs, coupled with their cryptic Facebook comment, a vlog that is apparently no longer on her website, and the fact that they have not shown any of Hannah’s more recent scans, which is in marked contrast to what they did when her tumor was shrinking? I sincerely hope I’m mistaken. I don’t want either Hannah or Laura to recur and sincerely hope that they are, indeed, disease free and remain so for decades to come. But just because either of them might be disturbed by my frank discussion is no reason for me not to discuss their cases, particularly given that they have both apparently agreed to assist Eric Merola in producing his latest propaganda-fest.

Laura Hymas is different in that she provides somewhat more suggestive evidence for a possible antitumor effect from antineoplastons, given the longer period of time since she finished her radiation therapy and since her still being in complete remission five and a half months after her first scan showing no residual tumor. However, her case is by no means the slam-dunk evidence that Burzynski supporters claim it to be (or, for that matter, that Merola touts it as in his upcoming movie), given that it has been less than six months since confirmation of a complete response. Moreover, given that HDAC inhibitors do seem to have some efficacy against glioblastoma, it is not unreasonable to expect that antineoplastons might actually have had activity in Laura’s case. Making claims, as Burzynski does, however, that his antineoplaston therapy is more efficacious than conventional therapy is unwarranted based on a single patient. Conventional therapy can produce durable remissions and complete responses, too, and, although they are still rare, they are becoming more common. That’s why legitimate randomized clinical trials are needed to determine if PB/antineoplastons have antitumor effects in humans; which tumors are sensitive; if there are any biomarkers of sensitivity; and to separate the signal from the noise. Anecdotes like those of Hannah Bradley and Laura Hymas can be suggestive, but in and of themselves prove nothing.

It’s also why what Burzynski appears to be doing is an incredible disservice to cancer patients. If, in fact, he has a treatment that is so much more effective against “untreatable” cancers than anything we currently have, then he should have been able to demonstrate it by now. His excuses, in fact, are pathetic. He trots out the old alternative cancer treatment excuse that big pharma, the FDA, and the “cancer industry” are out to get him because they don’t want a cure for cancer. You can see in Merola’s second trailer that parroting this hoary old chestnut beloved of cancer quacks is going to play a central role in Burzynski II. Burzynski claims he has no pharma funding and no resources to do proper clinical trials, despite registering over 60 clinical trials since the 1990s and publishing none of them. This is in marked contrast to startup companies with fewer resources than Burzynski managing to take a drug concept through clinical trials within a few years. For example, contrast Burzynski’s story to a story like that of PLX4032, which was taken through phase I and II trials rapidly and is now in phase III trials.

No, I don’t buy Burzynski’s excuses at all.

Burzynski is not doing what real scientists and clinical investigators do, and neither is Hideaki Tsuda. Publicizing their alleged research in a movie made by a Burzynski sycophant, toady, and lackey is just not the way science is supposed to be done, and his record, as demonstrated by the public record, appears dismal. Barring the publication of truly convincing clinical trial evidence by more sources than just Burzynski (given that Burzynski has already shown his methodology for conducting clinical trials to be questionable at best and that his preclinical data supporting his methods are at best weak and usually appear in publications that are not peer-reviewed), if we take in totality the evidence for the anti-cancer efficacy of PB along with all the evidence from the past 35 years for the anti-cancer efficacy (more properly, the lack of efficacy) of antineoplastons, the inescapable conclusion is that PB/antineoplastons might—I repeat, might—have very modest efficacy against some tumors through the HDAC inhibitor activity of PB. Whether that activity seen in some preclinical models truly exists and translates into human use and, more importantly, whether it is worth the not inconsiderable toxicity of antineoplastons as prescribed by Burzynski, are questions that Burzynski has, in my opinion, already shown that he will almost certainly never answer.

Comments

I really, REALLY want these two to be real success stories. I wish them nothing but good results, but the patients on The Other Burzynski Patient Group still haunt me. How many patients have to die and be conveniently ignored by Burzynski and his shills for each so-called lucky “success?”

I really do wish these people the best, and hope they both recover and enjoy long and happy lives. Having said that, I can’t bear to watch the videos – it’s like seeing a slow-motion car crash. This is one of those times when I wish I was religious and could pray to a gentle, merciful god.

I, too, hate the way the Burzynski shills use patients as human shields. It is one of the more grossly unethical things in which the clinic is complicit.

My own communications with Amelia Saunders’ father Richard suggest that while your comments were not exactly welcome (nobody likes a bucket of ice water poured over their head), they were at least listened to: he followed your advice and went to a really good radiologist with the MRIs, with the result that the family was at least prepared for the inevitable and little Amelia was cared for in a lovely hospice not far from me. And having originally thought to donate the remaining funds to “Yes To Life”, a group that supports all manner of quackery, the Saunders’ in the end gave the money to the hospice. I know that several UK skeptics also donated to the hospice in Amelia’s memory.

I was impressed throughout by the dignity that Richard showed. The man demonstrated genuine class. He is a hero. I think he still believes in Burzynski at east a little bit, but despite all that emotional investment he still put it aside when the chips were down and did what was best for his little girl, even though it meant giving up hope.

I cannot think about it without tearing up. It’s one of the most heart-rending situations I have ever encountered, including the death of my own sister. We wanted Amelia to survive, we all did, but we knew it was unlikely as did the folks at GOSH, who were also epic.

This is the flipside of the patient anecdote as used by Merola. Real people suffer real hurt, hope is built up and then cruelly destroyed, not by the clinic gently letting them down, but by other doctors who have to be the bad guy and give them the news they don’t want to hear.

Oncologists all lose patients. Most of them show amazing empathy and a commendable frankness about the chances of success. Burzynski is not cast in this mould, and that does him no credit. He is even deeper in denial about his patients’ disease than they might be. That is a terrible thing in a doctor who is supervising cancer patients. Realism absolutely must be at the core of any such conversation.

I’m curious – but have little time. In the Burzynski patients I have seen in the US, he tends to use the oral antineoplastins, in the ones out of the country, he uses the IV ones. Any suggestions as to why the difference?

In the US, he uses an FDA-approved drug, sodium phenylbutyrate (PB), because it is metabolized in the body into two of the antineoplastons. I suspect he favors PB in the US because he can claim he’s using the drug off-label rather than having to defend using an unapproved drug outside of a clinical trial. From what I can gather from various sources, patients who are eligible for one of his dubious “clinical trials” all get antineoplastons while those not eligible get PB plus his “personalized gene-targeted cancer therapy.”

@Orac – based on what has been written in “the Other Burzynski Patient Group” it sounds like that is exactly what is happening……

I also just read the review of the new Burzynski movie – I didn’t know whether to laugh or cry with how skewed the review was (might have been written by Merola himself). I will also point back to one bit of information the DJT provided – which was the Clinic’s own 10-K reports to the SEC, which point out that there are only 3 employees & the clinic itself is completely dependent on Dr. B for all of its operating capital…..

If you read between the lines, this means that Dr. B is pocketing the bulk of the money coming in to the clinic & only providing enough back to cover operating expenses. It is an easy way to hide profits.

Somewhat OT, but I wanted to alert the other Torontonians who hang out here that Dr. Oz’s favourite faith healer, the notorious sideshow act and sexual predator John of Fraud will be defiling our city with his presence this coming weekend: http://johnofgodlive.com/live/canada/program-info/. $188 a day or $514 for the whole weekend, going straight into that despicable charlatan’s pockets.

As for the other despicable charlatan being discussed here, I can only echo the other comments that for the sake of Hannah Bradley and Laura Hymas, I hope Burzynski’s treatment did them some good. I also wish they hadn’t had to part with so much cash and endure such discomfort in the process.

First, I notice that nowhere was there anything mentioned about enrolling Hannah on a clinical trial. Remember, part of the consent agreement with the Texas Attorney General
back in the late 1990s stated that Burzynski can distribute “antineoplastons” only to patients enrolled in FDA-approved clinical trials, unless or until the FDA approves his drugs for sale.

I mentioned this on your “friend’s” blog, but for the sake of anyone who hasn’t seen it and still thinks Burzynski is just being persecuted, I’ll say it again. Wayne Dolcefino, Count Stan’s newest mouthpiece PR consultant, when asked why patients are charged tens (or hundreds) of thousands of dollars to enrol on clinical trials, keeps repeating the following:

the vast majority of patients at the clinic are not involved in any clinical trial

Now Marc Stephens wasn’t exactly Stephen Hawking, but Wayne must have the intellectual capacity of soup if he thinks that he can deny something shady and unethical (charging to participate in trials) by admitting to something that’s illegal (selling drugs that are not approved). Talk about an own goal!

Like thenewme I’m also prone to rage and incredible sadness when reading TOBPG, and seeing every patient (and their family members) go down the same predictable path of being told “Wow, [terrible symptom] is a sign the tumour is dying!” right up until they die.

Thank you Orac for continuing to do this. You’re always tactful and respectful, and I’m sure that somewhere out there, exist people who have read your reasonable, factual debunking of Stan’s “miracle cure” and decided not to go to Houston or to subject their child to his “therapy”.

From Wikipedia: A Form 10-K is an annual report required by the U.S. Securities and Exchange Commission (SEC), that gives a comprehensive summary of a public company’s performance.

If Burzynski’s clinic is filing this form, it means they are a publicly traded company: any of us, if we were so inclined, could buy shares in Burzynski’s clinic. It also implies the existence of shareholders who would expect the clinic to be profitable–a perfectly reasonable expectation given the large amounts of money they charge clients. It further implies the existence of auditors who would have some knowledge as to where that money is going.

Granted that the SEC has been largely toothless over the last twelve years (they have had difficulty prosecuting the rather obvious fraud associated with the housing bubble), but if they were so inclined, and they thought something was fishy about the Burzynski Clinic’s finances, they could make Dr. Burzynski’s life very miserable indeed. I don’t know if what he’s doing actually violates SEC rules (IANAL), but if what Lawrence says is true, it looks quite fishy indeed.

@flip
I was watching “The Doctors” discuss Valerie Harper’s cancer and they sald that chemo agents have trouble getting past the blood-brain barrier, so you need high dosages to get effects. Maybe the same thing is happening here.

I am one of those who had few side effects to chemo, however, the dosage was reduced due to white-blood cell count, but I really had no obvious reaction to my FOLFOX treatment.

It also implies the existence of shareholders who would expect the clinic to be profitable–a perfectly reasonable expectation given the large amounts of money they charge clients.

BZYR is a penny stock (16 cents as of yesterday) with a rather pumpish-and-dumpish trading history to my eye. BRI hands out face-value warrants (and books them as expenses all the same) in lieu of compensation. I doubt that this is a long-term investment for the vast majority of the stockholders.

I wouldn’t be surprised if they are burying the patients with bad outcomes. It’s par for the course with alt-med. Homebirth midwives are infamous for silencing and deleting stories by mothers who lost their babies or experienced bad outcomes (damage to mom or baby) due to homebirth.

@Narad – I believe Dr. B was listed as the majority / sole stockholder, so any other stock issued is probably worthless paper (and as a penny-stock, that’s usually a guarantee). Given that Dr. B owns the building & the clinic rents it back from him, plus he provides the money to cover the expenses, it usually means that he is pocketing all the profits (hence the estate in which he lives).

Of the three employees that the clinic says they employ, I would be interested to see what their actual roles are. Now the DJT has brought those 10-Ks into the light (and I’ll also look up the end of year statements as well) it should be interesting to see exactly what other information can be gleamed.

At first blush, the clinic is nothing more than a front for Dr. B to hide his profits – since he can (and does) claim in the 10-K that the clinic doesn’t clear a profit / make money, because the clinic is paying Dr. B for “room and board” so to speak.

I lost my mother in law to glioblastoma multiforme just over a year ago, and was one of her caretakers. Just this week, I was finally able to bring myself to read the journal I kept, and my jaw dropped. Take the narrative of the Other Burzynsky Patient Group, remove all mention of Burzynski and neoplastons, and it was the same:

After surgery, the tumor shrank and she improved decidedly. There was hope. Symptoms crept up, were treated with medication, and subsided. Repeat. Lots of ups, lots of downs. Hoped for a miracle, searched for clinical trials. The tumor grew, she passed away with grace and dignity.

Big difference: She wasn’t consumed with nonstop bags of unbelievable levels of sodium and all its exhausting side effects, and water intake. She didn’t have to travel across the country while extremely ill. She had loving family and friends around her, and we experienced exquisitely lovely times together amid the exquisite trials, until it was time to say goodbye.

In retrospect I can’t imagine the process being interrupted by the highly trying ANP regimen, that, as we are learning from TOBPG, robs so many of the most precious of days.

At the end we did get suggestions to look into “that Clinic in Houston”, as well as a suggestion in the last 2 weeks to try aroma therapy because “we don’t know what amazing things it can do–it’s worth a try!” (They didn’t realize they were talking to a family of scientists, who held straight faces remarkably well). I am quite grateful for medical science and those who dedicate their lives to helping others.

I have metastatic colorectal cancer. I’m lucky in that it’s a common cancer with a good deal of evidence from clinical trials to guide my oncologists’ decisions. (@Keith B.: I’m about to start FOLFOX/RT. Glad to hear of someone who had a decent experience!)

If Burzynski and Tsuda have evidence–of efficacy or lack thereof–of their treatment, there is no reason not to publish. A movie is not a substitute for a paper in an actual peer-reviewed journal. If they have found an effective treatment, and they’re not publishing it because they would rather have money and/or fame, then they’re much worse than the “cancer industry” they’re criticizing.

My brother has just this week been diagnosed with lymphoma, with additional kidney involvement. He is currently in a hospital bed awaiting his second biopsy in three days. A third-cousin is his surgeon tomorrow, but that’s more a reflection on the region in which we reside than any planning on our part 😀

The kidney may be sacrificed (we won’t know for a while, but he has a spare). As a family, we are fans of science, and hold strong hope that evidence will provide us with more time with him, if not a cure. I know other relatives will attempt to persuade him to try alt-woo, but knowing my baby brother he will laugh them off and trust his medical team.

BRI hands out face-value warrants (and books them as expenses all the same) in lieu of compensation.

By itself, that’s not illegal. But I would guess that the employees who are thus compensated are probably not well advised about the insider trading rules that they are subject to. I don’t pretend to understand the rules, as some of them are quite arcane (you can only sell at certain times, and there may be some paperwork involved) and I have never been in a situation where they applied to me, but they do exist, and in a company of three employees it would be hard for any of them to argue that they aren’t insiders.

Is BRI one of those companies that encourages employees to put the 401(k) in company stock, e.g., by issuing stock as the company match? Again, not illegal, but a very dangerous thing to do (see Enron, which also was a Houston-based company).

@Eric – I have friends that have access to the various Public SEC Reports (one of those pay-databases). I’m going to email them to see if they will send me the last few years reports for the clinic….I would be very interested to see what other information might be available in the annual reports – which should also include things like employee compensation and such…..

Thanks for posting this, Orac. I think you did a good job of showing that you care, but I won’t be surprised if Burzynski’s sycophants quote mine you or, failing that, just plain lie about what you’ve said.

I do hope the patients get better. My rage is reserved for Burzynski, and always, if he’s actually onto something with his treatments, he’s still a monster for suppressing his research and making transparent excuses instead of just doing proper clinical trials. If he’s indeed a quack, I’m angry because he’s exploiting his desperate patients and using textbook quack tropes to trick them into supporting him.

Lawrence/Eric: I’m a Securities Attorney (have clients who have drugs in the different stages of the clinical trial process, which coupled with my own interest in the subjects Orac covers are why I hang out here).

I should have some time this afternoon; going to take a look at the 10-K reports and let you know what I think.

(And you shouldn’t need a pay database for the SEC reports. They’re all available on the SEC’s EDGAR system, which is publicly available on the SEC’s website)

Okay, so my curiosity got the better of me and I had to look right now.

Background: The Form 10-K is a required form for all public companies. It must be filed within 60, 75, or 90 days of the end of the company’s fiscal year, depending on the size of the company. As a “smaller reporting company”, meaning a company with less than $75 million in market capitalization (that’s a simplified defintion, but the best one here), his company is required to file 90 days after. The clinic’s fiscal year ends at the end of February, which means he filed on the last day possible in May (fairly common). The next Form 10-K he will file will be around May 28, 2013.

1. This is a very short 10-K. The amount of background information given, as compared to the 10-Ks I work on for similarly situated companies (companies with no approved drugs, but who have drugs in the clinical trial process) is very low.

2. The 10-K doesn’t include “Risk Factors”. Basically, in most 10-Ks, there’s a list of the risks that are inherent in investing in that stock (“Our drug trials may fail”, “We’re dependent on our senior researchers, and if any of them leave we’re in trouble”). That sort of thing. As a smaller reporting company, he’s technically not required to put in those risk factors. But most smaller companies do. Again, not a violation, but just something to note.

3. Same for the “Selected Financial Data”, which is usually an easy-to-read summary of the financial statements and balance sheets. Again, he’s not required to do this, but I don’t think I’ve ever seen a company skip it, even when they’re not required to add it.

5. The “Research Institute” has an IRB, and the Chairman of the IRB is on the Research Institute’s Board of Directors. Does that seem like a conflict of interest to anyone else?

6. Dr. Burzynski owns just under 82% of the stock. If he bumped that up to 90%, he could take the company private and not deal with any of these filings. I’m shocked he doesn’t do that. I’d recommend that he do it, given the low amount of money it would cost to do that.

7. The financial statements are in order. I can’t speak to how accurate they are, but they’re correctly presented, and they are apparently vetted by an independent public accountant.

8. Eric asked about employee compensation. According to this, the Research Institute pays out zero in employee compensation, at least to its executives (including Dr. Burzynski).

If anyone wants to look at it, I can send it in PDF or link to it on the SEC’s website.

5. The “Research Institute” has an IRB, and the Chairman of the IRB is on the Research Institute’s Board of Directors. Does that seem like a conflict of interest to anyone else?

Yep, it’s a COI. He would not be able to vote on or sit in on any IRB committee discussions of research being undertaken by the Research Institute where the research involves anything from which he could benefit. If he did, then that would violate Federal regulations.

One IRB I sat on, a member had a relative who worked for a company that developed a product that was being investigated. She had to sit out, and an alternate IRB member come in, when that research came up for discussion and vote.

6. Dr. Burzynski owns just under 82% of the stock. If he bumped that up to 90%, he could take the company private and not deal with any of these filings. I’m shocked he doesn’t do that. I’d recommend that he do it, given the low amount of money it would cost to do that.

That’s why I was surprised when Lawrence mentioned a 10-K. The clinic doesn’t seem to need capital from outside investors, and Burzynski wouldn’t have to disclose financial data to anyone other than the IRS and (if they exist) their Texas state counterparts.

(you can only sell at certain times, and there may be some paperwork involved)

These are call warrants, IIRC. Basically, an exchange of the right to purchase for marketing services. This is noted in the foreign-marketing agreement, but one might wonder about the extent to which it occurs domestically.

@Eric – I was surprised as well, though it does give Burnzynski an avenue to “publish” clinic results without any oversight or confirmation (like peer-reviewed publishing would require) – as our friend DJT kept pointing out (over and over and over again).

Even Wayne D. pointed to the 10-K as confirmation that Dr. B “has” published results….even if they don’t actually mean anything.

8. Eric asked about employee compensation. According to this, the Research Institute pays out zero in employee compensation, at least to its executives (including Dr. Burzynski).

How can Burzyinski afford to fund the clinic if Burzyinski is not receiving money from it? Where does the money come from, it’s not like he has a second job somewhere? 1. He came to America with $20 in his pocket
2. Worked for a research facility (IIRC)
3. Left facility to start his own clinic

There’s a step missing there, which is where he made millions of dollars to fund a clinic that supposedly spends millions on research and development. Unless of course it’s just a revolving door of money.

@flip – Dr. B provides all the operating capital for the clinic & also owns the building the clinic resides in and charges rent for the clinic (of an unknown amount), which means that the Clinic is probably paying Burzynski all of the money that comes in, while he turns around and gives back whatever money is necessary to continue to run operations….so yes, the money travels in one big circle, with a hefty chunk landing right in Dr. B’s bank account.

This way, he can hide whatever profits the clinic makes by charging them the identical amount…..

Off topic, apart from the neurology connection, but I can’t be the only person here who enjoys a good medical drama. I’m thoroughly enjoying the new TNT drama called ‘Monday Mornings’ based on Sanjay Gupta’s novel. I particularly like the inscrutable Dr. Park, an Oriental neurosurgeon whose bedside manner in persuading a patient to undergo neurosurgery consists of, “Not do, die”.

Yes it’s circular now. My point is that he didn’t set up the clinic with millions already – it’s unlikely anyway, unless he made a heck of a lot at his previous job. I’m just wondering where the start up funds came from.

My only idea is that he started with a skeleton of supplies, the building was initially rented, etc. And then when the money started coming in, he pocketed whatever was left over. Most of the Burzyinski fans never consider that his expensive trials that aren’t funded by outside sources would have needed start up funds – and never consider where those funds come from in the first place.

I watched the latest episode after writing the above, and was treated one of the main characters lecturing her colleagues about their arrogance and closed-mindedness about “non-western”, holistic medicine and gave the examples of ulcerative colitis being treated with whipworm eggs, maggots being used to “eat bacteria”, and fecal transplants in the treatment of C. diff., none of which are holistic in the slightest. She also trotted out the familiar litany of how awful the US is by various health measures in comparison to other countries and how “it can be said that our medicine here sucks”; as has been discussed here many times, unhealthy lifestyles, social inequality and poor access to medical care are the real problems.

Apologies to anyone else who also found themselves jumping up and down yelling at the screen thanks to my recommendation.

I’m not against everyone being supportive and sending good wishes to the patients discussed in the post, but personally, I don’t think that furthers our ability to move toward a culture of better acceptance of death–even (or especially) premature death (as in children, not as in keeping Grandma going two more months for a million dollars).

The idea that “hope” should be encouraged and people’s refusal to surrender it should be ignored is the kind of thinking that leads people to altie med to begin with.

I’m in no way suggesting that we not behave in a caring way to these people, but we should also use the opportunity to have a rational discussion of end-of-life, and how we can do that better. Ill people are so busy “hoping” for fairy dust that they throw away valuable time to simply be with loved ones or reflect on their lives and make arrangements for their survivors (if applicable).

It’s not cruel or uncaring to mention that the Emperor has no clothes–it might even save him further embarrassment.

I watched the latest episode after writing the above, and was treated one of the main characters lecturing her colleagues about their arrogance and closed-mindedness about “non-western”, holistic medicine and gave the examples of ulcerative colitis being treated with whipworm eggs, maggots being used to “eat bacteria”, and fecal transplants in the treatment of C. diff., none of which are holistic in the slightest.

Two of the three are not even “alt-med”, let alone “holistic”, having been trialled and adopted as valid treatments, and the whipworms are being used in a trial as we speak.

As a further aside – what is the point of the hand-held wobbly camera work so frequently used these days? My vision isn’t like that in real life when I am walking around, so it tends to destroy suspension of disbelief rather than enforce it..

As a further aside – what is the point of the hand-held wobbly camera work so frequently used these days? My vision isn’t like that in real life when I am walking around, so it tends to destroy suspension of disbelief rather than enforce it..

I just took a look at an MMs episode with the camera work in mind, and most of the time it matches the pace of the action, only adopting the wobbly, blurry hand-held style when things hot up, such as when someone is rushed into the ER with a doctor astride them on the trolley doing CPR . The camera actually whips around from a (fairly) steady shot to the afore-mentioned trolley as it crashes through the doors (along with a great line, “Can’t you at least go out on a date and not come back here humping on somebody”). It used to annoy/nauseate me, but I seem to have more or less gotten used to it over the years.

Do you know what seems like a conflict of interest to me? A former Monsanto attorney sitting on the supreme court Justice Thomas hearing cases involving Monsanto. And ruling in their favor every time. Then you have Michael Taylor a former attorney and public policy maker for Monsanto appointed to the FDA to a newly created position by President Obama. In investigating my remark I find that nearly everyone from Vilsack on down has some sort of connection to Monsanto. Now, here is my question. If we should, and I believe we should, be concerned over such gross conflict of interest, why shouldn’t I also consider that here? After all, Burzynski is your competitor. Is he really selling snake oil and profiting from those who are most ill among us, or does he just threaten the status quo?

Dr. B would be considered a “competitor” if he showed he actually had a valid & effective treatment…. because of his inability to actually publish the full results of his various clinical trials & allow replication of his process, he caters to the most vulnerable and gullible…….that’s not competition, that’s being a con man.